Clinical trials

• Participants receive high-quality cancer care and close observation by the research team.
• Participants have access to new treatments otherwise not available, which may prove more effective than standard treatment.
• Participants can help others by improving cancer treatment.
• Participants may have access to study medication at no cost.

Clinical trials are important to the future of health care. Researchers use trials to discover new treatments that work better than accepted treatments and/or work just as well but with less side effects for the patients. They are also the reason we have treatments at all. Clinical trials are used to develop new treatments in areas where none are available.

Clinical trials help drug companies evaluate whether to seek approval from the FDA. If a medicine isn’t as effective as the standard treatment, the FDA will most likely not approve it.

Participating in a clinical trial will not always benefit you directly, such as a biorepository, a clinical trial consisting of a blood draw or tissue donation. These trials are looking at biomarkers and keep samples in a biorepository to be used for research purposes. Although, there may not be a direct benefit to you, participating may help other people in the future who have the same disease if a test or treatment is developed.

To participate in a clinical trial, you will be asked to provide your consent. Your health care team will then evaluate if you are eligible to par take in the trial. Participants must meet a trial specific set of strict standards, or criteria. Once determined eligible, you can be enrolled in the clinical trial. As a participant in the trial, you will be asked to follow a structured program. There will be a specific schedule of tests, doctor appointments, and/or treatments. And you may be asked to keep a diary of your experience during this time. Your treatment team will include doctors, nurses, research coordinators, and other professionals who will help guide you through your journey.

To approve a medicine or treatment the FDA requires three phases. The fourth phase happens after the medicine or treatment has been approved.

Phase I: A new medicine is tested for the first time on a small group of healthy people or people with certain conditions or diseases. Researchers check the safety of the medicine or treatment, the best dose or schedule to use, and what types of side effects occur. During this phase, all the people involved in the study (patients, doctors and researchers) know what medicine is being used. These are called nonrandomized, nonblinded studies.

Phase II: The medicine or treatment is tested on a larger group of people with certain conditions or diseases. This phase helps researchers find out how well a medicine or treatment will work to treat a particular problem. Phase II trials are also usually nonrandomized, nonblinded studies.

Phase III: The medicine or treatment is tested on even larger groups. The medicine is studied to find out how well it works compared with standard treatment or placebo. Researchers also study whether the medicine improves specific areas in your life, such as how well you are able to keep your usual routine. Most medicines that reach this phase will be considered for FDA approval. During phase III trials, participants receive the study medicine, a placebo, or the standard treatment. Neither the participants, the doctors, nor the researchers know which person is getting which medicine. These are called randomized and double-blinded studies.

Phase IV: Medicines are also studied after they are approved. These studies can find new uses for the medicine, different ways to give it, or more safety information. For example, a medicine may be studied to see how well it works for a certain population, such as adults over the age of 65 or a certain racial group.

An institutional review board (IRB) must monitor and approve every clinical trial conducted in the US. The review board makes sure the risks are as low as possible and are worth any potential benefits.

The US government regulates most clinical research. There are specific rules protecting the participants. The standard ethical and legal rules for medical practice also apply to all clinical trials. Clinical trials adhere to a study specific plan or protocol that is carefully controlled. It maps out and explains what will happened and when in the study. It also details everyone’s involvement in the trial such as the lead researchers conducting the study. These researchers analyze the data and report results at scientific meetings, to medical journals, and to other agencies. Your name is not mentioned in these reports and remains confidential.

• A011801
  The COMPASSHER2 Trials (COMprehensive Use of Pathologic Response ASSessment to Optimize Therapy in HER2-Positive Breast Cancer): COMPASSHER2 Residual Disease (RD), A Double-Blinded, Phase III Randomized Trial of T-DM1 and Placebo Compared with T-DM1 and Tucatinib
  
  
• SWOG S1703
  Randomized Non-Inferiority Trial Comparing Overall Survival of Patients Monitored with Serum Rumor Marker Directed Disease Monitoring (STMDDM) Versus Usual Care in Patients with Metastatic Hormone Receptor Positive Breast Cancer

• Alliance A021703
  Randomized Double-Blinded Phase III Trial of Vitamin D Supplementation in Patients with Previously Untreated Metastatic Colorectal Cancer.

• GI004
  Colorectal Cancer Metastatic dMMR Immuno-Therapy (COMMIT) Study: A Randomized Phase III Study of mFOLFOX6/Bevacizumab Combination hemotherapy with or without Atezolizumab or Atezolizumab Monotherapy in the First-Line Treatment of Patients with Deficient DNA Mismatch Repair (dMMR) Metastatic Colorectal Cancer

• EA5163/S1709 INSIGNA
  A randomized, Phase III Study of Firstline Immunotherapy alone or in Combination with Chemotherapy in Induction/Maintenance or Postprogression in Advanced Nonsquamous Non?Small Cell Lung Cancer (NSCLC) with Immunobiomarker SIGNature?driven Analysis
  
  
• LUNGMAP
  A Master Protocol to Evaluate Biomarker-Driven Therapies and Immunotherapies in Previously-Treated Non-Small Cell Lung Cancer (Lung-MAP Screening Study)
  
  
• SWOG S1800D
  A Phase II/III Study of N-803 (ALT-803) Plus Pembrolizumab Versus Standard of Care in Participants with Stage IV or Recurrent Non-Small Cell Lung Cancer Previously Treated with Anti-PD-1 or Anti-PD-L1 Therapy (Lung-MAP Non-Match Sub-Study)

• S1803
  Phase III Study of Daratumumab/rHuPH20 (NSC- 810307) + Lenalidomide or Lenalidomide as Post-Autologous Stem Cell Transplant Maintenance Therapy in Patients with Multiple Myeloma (MM) Using Minimal Residual Disease to Direct Therapy Duration (DRAMMATIC Study)

• EAY131
  Molecular Analysis for Therapy Choice (MATCH)
  
  
• THR-CS-001
  Detecting cancers Earlier Through Elective plasma-based CancerSEEK testing-Ascertaining Serial Cancer patients to Enable New Diagnostic II (DETECT-ASCEND2)
  
  
• Alliance A212102
  Blinded Reference Set For Multicancer Early Detection Blood Tests
  
  
• Caris TCBIO-001-0710
  The Caris Biorepository Research Protocol